The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial

NCT07828262 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Hospital Research Institute

Phase

Phase 2

Started

2026-12

Last updated

2026-09-18

Condition(s) studied

Ankle ArthritisWound Complication

Investigational drug(s) / intervention(s)

Transexamic acidNormal Saline (0.9% NaCl)

Transexamic acid: Patients in the intervention group will receive 1.5g of TXA in 100ml normal saline (NS) solution. A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge.

Normal Saline (0.9% NaCl): Patients in the placebo group will receive 100ml normal saline (NS) solution intravenously. A second dose of 100ml normal saline will be given topically through a soaked sponge.

Study summary

Patients who undergo total ankle replacement surgery can sometimes develop problems with wound healing after their operation. These complications may include delayed healing, wound opening, or infection, which can lead to additional clinic visits, further surgery, and longer recovery times.

Tranexamic acid (TXA) is a medication that has been used safely for many years in many types of surgery to reduce bleeding. Some studies suggest that it may also improve wound healing after foot and ankle surgery by reducing bleeding and swelling around the surgical site. However, there is not enough high-quality evidence to know whether TXA truly improves outcomes for patients undergoing total ankle replacement.

This study is a pilot clinical trial designed to determine whether a larger study can be successfully carried out. Approximately 40 patients undergoing total ankle replacement surgery at The Ottawa Hospital will be randomly assigned to receive either TXA or a placebo (salt water solution). Neither the patients nor their health care team will know which treatment was given until the study is complete. All patients will receive standard surgical care and follow-up regardless of which group they are assigned to. Researchers will then collect information about wound healing, complications, additional surgeries, and infections at routine follow-up visits for up to six months after surgery.

The outcomes will be compared between patients in each group. The results of this pilot study will help determine whether a larger clinical trial is feasible and may provide early information about whether TXA could improve recovery after total ankle replacement surgery. Ultimately, this research aims to improve patient outcomes and reduce complications following ankle replacement surgery.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient undergoing either primary or revision ankle replacement surgery * Patient is considered to benefit from surgical management at the treating surgeon's discretion * The patient is willing and able to provide written informed consent * The patient is willing and able to comply with post-operative rehabilitation protocols and all follow-up visits Exclusion Criteria: * Pregnant or breastfeeding patient * Uncontrolled diabetes (HgbA1C \> 8) * Known allergy or contraindication for tranexamic acid use including: presence of coronary stents, cerebrovascular event in the last six months, known thromboembolic disorder, hepatic dysfunction, impaired renal clearance, medications with known drug interactions\*\*\* * Lateral-based ankle replacement system * Patient receiving anticoagulation therapy * Investigator concerns about study compliance * Medically unfit for surgery or anesthetic * Acquired color vision problems that are not genetics * There are potential drug-drug interactions leading to myocardial infarction after coadministration of tranexamic acid with hormonal contraceptives, hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine, or nitroglycerin. Therefore, patients on these medications will be excluded.

Primary outcome measure(s)

Recruitment rate — 12 months
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months

Trial sites (1)

Facility	City	Region	Status
The Ottawa Hospital Civic Campus	Ottawa	Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07828262 on ClinicalTrials.gov ↗ ← All trials in Canada